← FDA DRUG APPROVALS

FDA NDA · NDA211580

SPY AGENT GREEN KIT

Sponsor: NOVADAQ TECH

APPLICATION
NDA211580
TYPE
NDA
ORIGINAL APPROVAL
2018-11-21
LATEST ACTION
2023-06-05
ROUTE
INTRAVENOUS, INTERSTITIAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

SPY AGENT GREEN KIT · ReferencePrescription
INDOCYANINE GREEN 25MG/VIAL · POWDER · INTRAVENOUS, INTERSTITIAL

Approval history

2023-06-05Efficacy · Supplement 6 · standard — Label ↗AP
2022-03-16Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2021-03-13Manufacturing (CMC) · Supplement 2 — Label ↗AP
2018-11-21Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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